Implementing lean methodologies within a maintenance organization

Abstract

The primary goal of the project was to make the machine maintenance process more efficient. In order to do this, we conducted a 3-day Value Stream Mapping workshop, during which we generated a map of the present value stream. We identified shortcomings and inefficiencies within this value stream, and then mapped out a future state Value Stream, creating a 90-day action plan to move towards that desired future state. This action plan relied heavily upon measuring and improving key performance indicators, which allowed us to make objective measures of our progress. A second internship objective was to reduce the number of clean room re-sanitizations. Currently, clean rooms undergo a costly and time-consuming re-sanitization whenever an air handler is shut down for a brief period of time. It is likely that some of these cleanings are unnecessary, and eliminating extraneous cleanings could reduce maintenance costs significantly. In order to reduce unnecessary clean room re-sanitizations, we designed and conducted a study to measure environmental standards during an air handler shutdown. Genzyme's Validation and Quality Control Departments approved this experimental plan prior to execution. We shut down an air handler that supplied a clean room, and monitored the air for viable and non-viable particles for several hours. Viable particulate levels did not exceed action limits during a four-hour shutdown, and non-viable particulates dropped to pre-experiment levels as soon as we re-started the air handler. Based on these results, we conclude that air-handler shutdowns should not require room re-sanitization.